Evidence of CholecystectomyNCT01412996
Quality of Life Measures After Single Access Vs Conventional Laparoscopic Cholecystectomy: Prospective Randomized Study.
A study testing surgery in people with Evidence of Cholecystectomy, run by Mansoura University at 1 site in Egypt.
Trial summary
This study aimed to compare the short term outcomes between SALC and conventional laparoscopic cholecystectomy (CLC). Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Evidence of Cholecystectomy
- What is being tested?
- surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteEgypt
- Study dates
- Nov 2009to Jan 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- GALL BLADDER STONES
Who cannot join
- ACUTE CHOLECYSTITIS
- PREVIOUS LAPAROTOMY
- ASA ABOVE 3
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single Access Laparoscopic Cholecystectomy
This study aimed to compare the short term outcomes between SALC and conventional laparoscopic cholecystectomy (CLC).
Read the detailed description
In a prospective study, two hundred fifty patients with symptomatic gall bladder stone were randomized to SALC or conventional laparoscopic cholecystectomy (CLC) (125 in each group). The primary endpoint of this study was to assess the total outcomes of quality of life using EuroQoL EQ-5D questionnaire. The secondary endpoints were postoperative pain, analgesia requirement and duration, operative time, perioperative complications, estimated blood loss, hospital stay, cosmoses outcomes and number of days required to return to normal activities.
- Conditions
- Evidence of Cholecystectomy
- Being tested
- surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgeryProcedure or surgery
Also called SALC, GROUP I
single ACCESS laparoscopic cholecystectomy
SURGERYOther
Also called CLC, GROUP II
CONVENTIONAL LAPAROSCOPIC CGOLECYSTECTOMY
| Study group | Role | What they receive |
|---|---|---|
| single ACCESS cholecystectomy | Active comparator | single ACCESS laparoscopic cholecystectomy Receives: Procedure: surgery |
| traditional | Active comparator | conventional laparoscopic cholecystectomy Receives: Other: SURGERY |
What is being measured
The primary outcome is the main question the study is designed to answer.
QUALITY OF LIFE
Quality of life was the primary endpoint of this study assessed by EuroQoL EQ-5D 9 questionnaire preoperatively, 1 week, 1 and 6 months after surgery. The EQ-5D is a validated questionnaire which consists of 2 pages: the EQ-5D descriptive system and EQ visual analogue scale (EQ VAS). The WQ-5D-descriptive system consists of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, extreme problems.
Measured: PREOPERATIVEELY, after 1 WEEK, 1 and 6 months postoperative
Secondary outcomes (5)
operative time
(defined as the interval between the initial skin incision and skin closure)
Measured: 2 hours
postoperative pain
using verbal analogue scale (VAS) from 0 to 10 (0 = no pain, 10 = severe pain)
Measured: 5 days
days to return to normal activity (RTNA)
patients were contacted by phone every day until they are able to return to their normal daily works
Measured: 10 days
COSMOSIS OUTCOMES
cosmetic outcomes 1 and 6 months after surgery using Patient and Observer Scar Assessment Scale (POSAS)(10), it comprises two distinct series of Visual Analogue Scale (VAS) instruments: one is self-assessed by the patient and one by an independent doctor, ranging from 1 (poor) to 10 (excellent)
Measured: 1 AND 6 MONTHS
ANALGESIC REQUIRMENT
NOMBERS OF ANALGESIC TABLETS AND NO. OF DAYS ANALGESIA NEEDED
Measured: POSTOPERATIVE PERIOD
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2011 (estimated)
- Study startNov 2009
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Evidence of CholecystectomyStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MOHAMED ABDELLATIF, Mansoura University
- Investigators
- RAMADAN ELLITHY, MD, Study chair, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01412996
- Sponsor's protocol ID
- Single access chOLECYSTECTOMY
- Status last verified
- Feb 2012
- First submitted
- 4 Aug 2011
- Last updated
- 27 Feb 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Access Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT01412996
- Acronym / sponsor ID
- Single access chOLECYSTECTOMY
- Conditions
- Evidence of Cholecystectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 9 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aimed to compare the short term outcomes between SALC and conventional laparoscopic cholecystectomy (CLC).
Detailed description
In a prospective study, two hundred fifty patients with symptomatic gall bladder stone were randomized to SALC or conventional laparoscopic cholecystectomy (CLC) (125 in each group). The primary endpoint of this study was to assess the total outcomes of quality of life using EuroQoL EQ-5D questionnaire. The secondary endpoints were postoperative pain, analgesia requirement and duration, operative time, perioperative complications, estimated blood loss, hospital stay, cosmoses outcomes and number of days required to return to normal activities.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| single ACCESS cholecystectomy | Active comparator | Procedure: surgerysingle ACCESS laparoscopic cholecystectomy |
| traditional | Active comparator | Other: SURGERYconventional laparoscopic cholecystectomy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- GALL BLADDER STONES
Key exclusion criteria (3 listed)
- ACUTE CHOLECYSTITIS
- PREVIOUS LAPAROTOMY
- ASA ABOVE 3
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| surgeryAlso: SALC, GROUP Isingle ACCESS laparoscopic cholecystectomy | Procedure or surgery | single ACCESS cholecystectomy |
| SURGERYAlso: CLC, GROUP IICONVENTIONAL LAPAROSCOPIC CGOLECYSTECTOMY | Other | traditional |
Primary outcome
QUALITY OF LIFE
Time frame: PREOPERATIVEELY, after 1 WEEK, 1 and 6 months postoperative
Quality of life was the primary endpoint of this study assessed by EuroQoL EQ-5D 9 questionnaire preoperatively, 1 week, 1 and 6 months after surgery. The EQ-5D is a validated questionnaire which consists of 2 pages: the EQ-5D descriptive system and EQ visual analogue scale (EQ VAS). The WQ-5D-descriptive system consists of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, extreme problems.
5 secondary outcomes
operative time
Time frame: 2 hours
postoperative pain
Time frame: 5 days
days to return to normal activity (RTNA)
Time frame: 10 days
COSMOSIS OUTCOMES
Time frame: 1 AND 6 MONTHS
ANALGESIC REQUIRMENT
Time frame: POSTOPERATIVE PERIOD
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2012.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
RAMADAN ELLITHY, MD study chair
Mansoura University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing surgery in people with Evidence of Cholecystectomy, run by Mansoura University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
QUALITY OF LIFE (time frame: PREOPERATIVEELY, after 1 WEEK, 1 and 6 months postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2012.